Evaluation of [18F]APN-1607 as a PET Biomarker for Longitudinal Change in Tau Pathology in Participants With Progressive Supranuclear Palsy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Invicro
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.
研究概览
简要总结
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP.
详细描述
The overall goal of this protocol is to evaluate [18F]APN-1607 as a PET radiotracer for measuring longitudinal change in tau pathology in participants with PSP. The specific objectives are:
- To characterize and demonstrate the longitudinal progression of tau deposition in vivo in participants with PSP.
- To determine optimal PET analysis parameters for [18F]APN-1607 quantification.
- To characterize the stability of tau deposition in vivo over time in healthy volunteers (HVs).
- To evaluate consistency of [18F]APN-1607 quantification in characterizing tau deposition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
[18F]APN-1607
Participants will receive an IV bolus injection of [18F]APN-1607, followed by PET brain imaging.
干预措施: [18F] APN-1607 (Drug)
结局指标
主要结局
Change in standardized uptake value ratios (SUVRs) of regional [18F]APN-1607.
时间窗: 72 weeks
The within-group change in standardized uptake value ratios (SUVRs) of regional \[18F\]APN-1607 binding within a priori defined cortical and subcortical brain regions from Baseline to Week 36 and Week 72.
次要结局
未报告次要终点